Cytosorbents Corp Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Michael Sarcone - Jefferies - Analyst : I guess just to start, for DrugSorb and the regulatory process, have you seen any impacts from the new US administration just on regulator staffing? And I guess what gives you confidence that you can continue to reiterate, you'll see clearance by year-end? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 31, 2025 / 8:30PM, CTSO.OQ - Q4 2024 Cytosorbents Corp Earnings Call

Question: Michael Sarcone - Jefferies - Analyst : Okay. Got it. And then just when you do get clearance, you talked about a controlled launch before ramping to a full commercial launch. Can you just give us a sense of what are the key things you'll be looking for and how that may impact how you hone your commercial strategy?

Question: Michael Sarcone - Jefferies - Analyst : Got it. That's helpful, Pete. And I guess just last one for me. Can you give us the latest and greatest on your thoughts on what kind of or size commercial organization you might need to fully commercialize, particularly in the US?

Question: Sean Lee - H.C. Wainwright - Analyst : My first question is just on the CytoSorb market. So could you give us a bit more color on what was the main growth drivers behind the high growth that we see in sales outside Germany as well as distributors? And why did that not apply to the German market?

Question: Sean Lee - H.C. Wainwright - Analyst : Sorry. My apologies.

Question: Sean Lee - H.C. Wainwright - Analyst : Apologies. I thought I was -- I might have been cut off. I thought you've finished answering already.

Question: Sean Lee - H.C. Wainwright - Analyst : Great. My last question is on the operational side. I think you mentioned that the company is targeting near cash breakeven in the core business by the end of this year. So I was wondering if you can provide a bit of color on what metrics do you need to hit to reach that breakeven in terms of revenues and gross margins and such?

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : Just have a quick clarification on that last question on the breakeven. That assumes no DrugSorb-ATR revenues domestically or Canada. Is that correct?

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : Just being hypothetical, the second part of the question is, if you get early FDA clearance, the commercialization takes a relatively quick time and you could get DrugSorb revenues in the fourth quarter. I mean, does that change the profitability level? Or is it possible? Do you know where I'm getting that?

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : Got it. So 2026 could be a very nice year going forward in terms of margins if it gets approved. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 31, 2025 / 8:30PM, CTSO.OQ - Q4 2024 Cytosorbents Corp Earnings Call

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : Just going back to FDA real quick. Can they -- I forget, can they ask for anything else at this point, more data, clarifications? Or is the only thing left to clearance?

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : So you have interactive discussions with them. It's not just like a onetime AIR or anything like that, okay?

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : Got it. All right. One last quick financial one. The pro forma cash of $17 million does not include the Q1 2025 burn. So we can assume that maybe cash as of today, and you obviously don't have to say exactly is $14 million, $15 million in that range.

Question: Tom Kerr - Zacks Small-Cap Research - Analyst : All right. Just want to make sure that wasn't included in there. That's all I have for right now.